Associate Clinical Data Facilitator

Novo Nordisk A/S; Bengaluru; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Novo Global Business Services (GBS) in Bangalore seeks an Associate Clinical Data Facilitator to ensure data accuracy and regulatory compliance for submission. You will prepare forms and regulatory documents, and use Python, VBA and Power BI to automate repetitive tasks, boosting efficiency.

You will collaborate with Clinical Data Management & Programming, Regulatory Affairs and vendors to support eCTD submissions and CDISC standards in a global environment.

Qualifications

• Master’s or Bachelor’s degree in Life Science, CS, IT or equivalent.
• 2–3 years in the pharmaceutical industry.
• Strong knowledge of Python, VBA/macros, Power BI and automation tools.
• Familiarity with GxP, CDISC and eCTD requirements.
• Excellent communication and fluent English.
• Able to collaborate across regions and teams.
• Prefers 2+ years in clinical data management or related areas.

Responsibilities

• Own the quality and submission-readiness of clinical data forms for assigned trials.
• Compile, bookmark, merge and hyperlink sample and completed (e)CRFs and appendices for reports.
• Prepare (e)CRFs and CDISC submission documents to meet eCTD standards.
• Support decommissioning of EDC/eCOA systems and archival tasks.
• Manage scanning, tracking and archival of paper documents per records requirements.
• Identify repetitive tasks and drive automation using Python, VBA/macros and Power BI.

Skills

Attention to detail

English fluency

Cross-functional collaboration

Education

Master’s or Bachelor’s degree in Life Science/CS/IT

Tools

Python

VBA/macros

Power BI

CDISC/eCTD knowledge

Job description

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Company:Novo Global Business Services (GBS)
Department: Research & Development
Location: Bangalore, India

Your impact begins here

As Associate Clinical Data Facilitator in Global Business Services in Bangalore, you will make sure the clinical trial data behind Novo’s treatments is accurate, compliant and ready for submission. You will prepare the forms and documents regulatory authorities review, and use Python, VBA and Power BI to replace repetitive manual work with smarter, faster ways of working.Your work helps new treatments move through clinical development with speed and confidence, for people living with serious chronic diseases.

What you’ll bring

You thrive in a detail-oriented, globally connected environment and you are energised by finding better ways to get things done. You bring:

• A Master’s or Bachelor’s degree in Life Science, Computer Science, Information Technology, Clinical Information Management or an equivalent qualification.
• A minimum of 2–3 years of experience in the pharmaceutical industry.
• Strong working knowledge of Python, VBA/macros, Power BI and related automation tools, with hands‑on experience in process simplification and troubleshooting.
• Familiarity with GxP guidelines, drug development processes and clinical data standards, including CDISC and eCTD requirements.
• Excellent communication, presentation and coordination skills, with fluent written and spoken English.
• The ability to collaborate effectively across professional, regional and cultural boundaries
• Preferrably, at least 2 years of experience within clinical data management systems, project management or related areas.

What you’ll do

You will own the quality and submission-readiness of clinical data forms for your assigned trials, while making the way the team works simpler and more automated.

• Compile, bookmark, merge and hyperlink sample and completed (e)CRFs, and appendices for Clinical Trial Reports and Non-interventional Study Reports, and make sure they are archived in EDMS on time.
• Prepare (e)CRFs and CDISC submission documents (aCRF, cSDRG) to meet eCTD compliance standards, run electronic quality control checks and support submission deliverables at project level.
• Support the decommissioning of EDC and eCOA systems, including retrieval and archival of audit trails, access reports, Services Documentation Packages and Sponsor archive packages.
• Manage the scanning, tracking and archival of paper-based clinical documents, such as CRFs and patient diaries, in line with records management requirements.
• Identify repetitive manual activities and build sustainable improvements using Python, VBA/macros, Power BI and other AI tools.
• Take ownership of your assigned trials: spot risks to quality or timelines early, propose corrective actions and align on deliverables with stakeholders.

Who you’ll work with

You will join the Clinical Data Facilitator team within Clinical Data Management & Programming, part of Global Business Services in Bangalore. The team manages clinical data forms from end to end across Novo’s global trial portfolio, working where clinical data management, regulatory submissions and process innovation meet. In Research & Development, colleagues explore scientific ideas and advance them towards clinical testing. Curiosity, data, technology, collaboration and operational excellence come together to help meet future health needs.Day to day, you will partner with Clinical Data Managers, SDTM Programmers, Clinical Operations and Regulatory Affairs, as well as vendors and CROs. Together you will agree on deliverables and timelines, speak up early when something is at risk, and keep trials moving with clarity.

What you can expect here

You will work in a collaborative, international setting where your expertise is valued and your ideas for doing things better are welcome. You will build new skills by working with colleagues across the clinical data value chain, and by developing your automation and AI tool capabilities on real work that the team uses every day.

You will be supported to perform at your best and trusted to take ownership of your trials. Clear expectations and a culture that rewards results mean you can see the effect of your work.

Start now

Your impact begins today. Lasting Health Starts Now – and your contribution can start with it.

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